SI2691112T1 - Stabilne formulacije protiteles za humani programiran smrtni receptor pd-1 in sorodna zdravljenja - Google Patents
Stabilne formulacije protiteles za humani programiran smrtni receptor pd-1 in sorodna zdravljenja Download PDFInfo
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- SI2691112T1 SI2691112T1 SI201231319T SI201231319T SI2691112T1 SI 2691112 T1 SI2691112 T1 SI 2691112T1 SI 201231319 T SI201231319 T SI 201231319T SI 201231319 T SI201231319 T SI 201231319T SI 2691112 T1 SI2691112 T1 SI 2691112T1
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- 238000009472 formulation Methods 0.000 title claims abstract 7
- 239000000203 mixture Substances 0.000 title claims abstract 7
- 238000011282 treatment Methods 0.000 title claims 9
- 108091007744 Programmed cell death receptors Proteins 0.000 title abstract 3
- 239000000427 antigen Substances 0.000 claims abstract 4
- 108091007433 antigens Proteins 0.000 claims abstract 4
- 102000036639 antigens Human genes 0.000 claims abstract 4
- 239000012634 fragment Substances 0.000 claims abstract 4
- 206010028980 Neoplasm Diseases 0.000 claims abstract 2
- 238000000034 method Methods 0.000 claims abstract 2
- 102100023990 60S ribosomal protein L17 Human genes 0.000 claims 10
- 101710089372 Programmed cell death protein 1 Proteins 0.000 claims 10
- 239000008194 pharmaceutical composition Substances 0.000 claims 10
- 239000007788 liquid Substances 0.000 claims 9
- 125000000539 amino acid group Chemical group 0.000 claims 4
- 239000007864 aqueous solution Substances 0.000 claims 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 3
- 229930006000 Sucrose Natural products 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 229940068968 polysorbate 80 Drugs 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- 238000002560 therapeutic procedure Methods 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 239000012931 lyophilized formulation Substances 0.000 claims 1
- 201000001441 melanoma Diseases 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- 208000037581 Persistent Infection Diseases 0.000 abstract 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/44—Antibodies bound to carriers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- Animal Behavior & Ethology (AREA)
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- Molecular Biology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Communicable Diseases (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Endocrinology (AREA)
- Virology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (14)
- STABILNE FORMULACIJE PROTITELES ZA HUMANI PROGRAMIRAN SMRTNI RECEPTOR PD-1 IN SORODNA ZDRAVLJENJA PATENTNI ZAHTEVKI1. Stabilna liofilizirana formulacija anti-humanega PD-1 protitelesa, izdelana z liofilizacijo vodne raztopine, ki obsega: a) 25-100 mg/ml anti-humanega PD-1 protitelesa; b) 70 mg/ml saharoze; c) 0,2 mg/ml polisorbata 80; in d) 10 mM histidinski pufer pri pH 5,0 - pH 6,0, in kjer protitelo obsega: lahko verigo, ki obsega aminokislinske ostanke 20 do 237 SEQ ID NO: 36 in težko verigo, ki obsega amino kislinske ostanke 20 do 466 SEQ ID NO: 31.
- 2. Stabilna tekoča farmacevtska formulacija anti-humanega PD-1 protitelesa, ki obsega: a) 25-100 mg/ml anti-humanega PD-1 protitelesa; b) 70 mg/ml saharoze; c) 0,2 mg/ml polisorbata 80; in d) 10 mM histidinski pufer pri pH 5,0-6,0, kjer protitelo obsega: lahko verigo, ki obsega aminokislinske ostanke 20 do 237 SEQ ID NO: 36 in težko verigo, ki obsega amino kislinske ostanke 20 do 466 SEQ ID NO: 31.
- 3. Formulacija po zahtevku 1 ali 2, kjer je anti-humano PD-1 protitelo prisotno pri 25 mg/mL v vodni raztopini.
- 4. Formulacija po zahtevku 1,2 ali 3, kjer ima vodna raztopina pH 5,5.
- 5. Formulacija po katerem koli od predhodnih zahtevkov, kjer je protitelo h409A11.
- 6. Stabilna liofilizirana farmacevtska formulacija po zahtevku 1, kjer vodna raztopina obsega 25,0 mg/ml anti-humanega PD-1 protitelesa, 1,55 mg/ml histidina, 0,2 mg/ml polisorbata 80, 70 mg/ml saharoze in ima pH od 5,5; kjer je anti-humano PD-1 protitelo h409A11.
- 7. Tekoča farmacevtska formulacija po katerem koli od zahtevkov 2 do 6, za uporabo pri metodi zdravljenja s terapijo.
- 8. Tekoča farmacevtska formulacija za uporabo po zahtevku 7, kjer je terapija zdravljenje raka.
- 9. Tekoča farmacevtska formulacija za uporabo po zahtevku 8, kjer je doza izbrana izmed 1,0, 3,0 in 10 mg/kg ki se dajejo v intervalih 14 dni ali 21 dni v celotnem času zdravljenja.
- 10. Tekoča farmacevtska formulacija za uporabo po zahtevku 8, kjer se anti-humano PD-1 protitelo ali njegov antigen vezavni fragment daje v odmerku 5,0 mg/kg ali 10 mg/kg, ki se daje v intervalih vsake 2 tedna ali vsake 3 tedne v teku zdravljenja.
- 11. Tekoča farmacevtska formulacija za uporabo po zahtevku 8, kjer je terapija zdravljenje melanoma, pri čemer se anti-humano PD-1 protitelo ali njegov antigen vezavni fragment daje v odmerku 3,0 mg/kg, ki se daje v intervalih vsake 3 tedne v teku zdravljenja.
- 12. Tekoča farmacevtska formulacija za uporabo po zahtevku 8, ki se daje v 30-minutni IV infuziji.
- 13. Tekoča farmacevtska formulacija za uporabo po katerem koli od zahtevkov 8-12, kjer je zdravljenje naivnega subjekta.
- 14. Tekoča farmacevtska formulacija za uporabo po katerem koli od zahtevkov 8-12, kjer je zdravljenje subjekta, ki je bil predhodno zdravljen z dodatnimi kemoterapevtiki.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161470121P | 2011-03-31 | 2011-03-31 | |
| PCT/US2012/031063 WO2012135408A1 (en) | 2011-03-31 | 2012-03-29 | Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments |
| EP12763896.3A EP2691112B1 (en) | 2011-03-31 | 2012-03-29 | Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2691112T1 true SI2691112T1 (sl) | 2018-07-31 |
Family
ID=46931903
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201231319T SI2691112T1 (sl) | 2011-03-31 | 2012-03-29 | Stabilne formulacije protiteles za humani programiran smrtni receptor pd-1 in sorodna zdravljenja |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US9220776B2 (sl) |
| EP (2) | EP2691112B1 (sl) |
| JP (1) | JP6014116B2 (sl) |
| KR (4) | KR102031020B1 (sl) |
| CN (2) | CN107854439A (sl) |
| AU (1) | AU2012236479B2 (sl) |
| CA (1) | CA2830806C (sl) |
| CY (1) | CY1120359T1 (sl) |
| DK (1) | DK2691112T3 (sl) |
| ES (1) | ES2676205T3 (sl) |
| HK (1) | HK1256245A1 (sl) |
| HR (1) | HRP20181139T1 (sl) |
| HU (1) | HUE039209T2 (sl) |
| LT (1) | LT2691112T (sl) |
| MX (1) | MX341076B (sl) |
| PL (1) | PL2691112T3 (sl) |
| PT (1) | PT2691112T (sl) |
| RS (1) | RS57492B1 (sl) |
| RU (2) | RU2563346C2 (sl) |
| SI (1) | SI2691112T1 (sl) |
| TR (1) | TR201810298T4 (sl) |
| WO (1) | WO2012135408A1 (sl) |
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| EP2535354B1 (en) * | 2007-06-18 | 2017-01-11 | Merck Sharp & Dohme B.V. | Antibodies to human programmed death receptor pd-1 |
| SI2415470T1 (sl) | 2009-03-30 | 2016-12-30 | Eisai R&D Management Co., Ltd. | Liposomski sestavek |
| US20110020312A1 (en) | 2009-05-11 | 2011-01-27 | Niven Rajin Narain | Methods for treatment of metabolic disorders using epimetabolic shifters, multidimensional intracellular molecules, or environmental influencers |
| KR102031020B1 (ko) | 2011-03-31 | 2019-10-14 | 머크 샤프 앤드 돔 코포레이션 | 인간 프로그램화된 사멸 수용체 pd-1에 대한 항체의 안정한 제제 및 관련된 치료 |
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| UA117466C2 (uk) * | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
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